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Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, MA Facility of Bristol-Myers Squibb

Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Abatacept (BMS-188667) (Biological)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are comparable in healthy subjects

Clinical Details

Official title: A Randomized, Open-label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of Abatacept (BMS-188667) Drug Products Using Active Pharmaceutical Ingredient Manufactured at Devens, MA Site Relative to Active Pharmaceutical Ingredient Manufactured at Lonza, NH in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Single-dose pharmacokinetic parameter Maximum observed serum concentration (Cmax) of Abatacept (BMS-188667) will be derived from serum concentration versus time data

Single-dose pharmacokinetic parameter Time to reach Cmax in serum (Tmax) of Abatacept (BMS-188667) will be derived from serum concentration versus time data

Single-dose pharmacokinetic parameter Area under the serum concentration-time curve from time zero to 28 days [AUC(0-28 days)] of Abatacept (BMS-188667) will be derived from serum concentration versus time data

Single-dose pharmacokinetic parameter Area under the serum concentration-time curve from zero to the last time of the last quantifiable concentration [AUC(0-T)] of Abatacept (BMS-188667) will be derived from serum concentration versus time data

Single-dose pharmacokinetic parameter Area under the serum concentration-time curve from time zero extrapolated to infinity [AUC(INF)] of Abatacept (BMS-188667) will be derived from serum concentration versus time data

Single-dose pharmacokinetic parameter Terminal phase elimination half-life in serum (T-HALF) of Abatacept (BMS-188667) will be derived from serum concentration versus time data

Single-dose pharmacokinetic parameter Total Body Clearance (CLT) of Abatacept (BMS-188667) will be derived from serum concentration versus time data

Single-dose pharmacokinetic parameter Volume of distribution at steady-state (Vss) of Abatacept (BMS-188667) will be derived from serum concentration versus time data

Secondary outcome:

Immunogenicity determination will be based on titers of anti Abatacept and anti-CTLA-4-T antibodies in serum over time

Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests

Detailed description: Primary Purpose of this study is to compare the pharmacokinetic (PK) of Abatacept (BMS-188667) manufactured at Lonza relative to Abatacept (BMS-188667) manufactured at Devens, MA facility following a single intravenous infusion of 750 mg in healthy subjects

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy subjects as determined by no clinically significant deviation from normal in

medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations

- Body weight will be between 60 and 100 kg, inclusive

Exclusion Criteria:

- Any significant acute or chronic medical illness

- Any major surgery within 4 weeks of study drug administration

- Smoking more than 10 cigarettes per day

- Recent (within 6 months of study drug administration) drug or alcohol abuse.

- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human

Immunodeficiency Virus-1, Human Immunodeficiency Virus-2 antibody

- History of any significant drug allergy or asthma

- Women who are pregnant or breastfeeding and/or unwilling or unable to use an

acceptable method to avoid pregnancy for the entire study period

Locations and Contacts

Additional Information

Starting date: October 2011
Last updated: September 22, 2011

Page last updated: December 08, 2011

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